Wednesday, May 09, 2007

Depression, Antidepressants, and the Risk of Suicide

http://content.nejm.org/cgi/content/full/NEJMp078015?query=TOC
On May 2, 2007, the Food and Drug Administration (FDA) ordered that all antidepressant medications carry an expanded black-box warning incorporating information about an increased risk of suicidal symptoms in young adults 18 to 24 years of age. Since October 2004, antidepressants have been required to have a black-box warning indicating that they are associated with an increased risk of suicidal thinking, feeling, and behavior in children and adolescents.
The new warning also states that there is no evidence of an increased risk for adults older than 24 years of age and that the risk is actually decreased for adults 65 years of age or older. Strikingly, the label states that "depression and other serious psychiatric disorders are themselves associated with increases in the risk of suicide," which makes it the first black-box warning to note that a disease itself carries risk — and implies that there is risk in not using the very medication being warned about.
The new warning was developed in the wake of a December 2006 meeting of the FDA's Psychopharmacologic Drugs Advisory Committee, which focused on the controversial link between antidepressants and suicide risk in adults. During an often contentious public session, the advisory committee heard from psychiatric experts and from aggrieved family members, who sometimes expressed outrage at the FDA when they spoke of the death of loved ones who had taken antidepressants. In the end, the committee voted 6 to 2 in favor of extending the black-box warning to include adults 18 to 24 years of age.
The notion that antidepressants might be associated with an increased risk of suicidality (suicidal ideation, behavior, or both) in some patients is hardly new. Clinicians have known for years that during the first few weeks of treatment with antidepressants, some patients become "activated" — energized and agitated — before their depressed mood lifts, and that combination makes them more likely to act on preexisting suicidal impulses. But because suicidal thinking, feeling, and behavior are core symptoms of depression, there is no way to know whether suicidal symptoms that develop during treatment are due to the underlying illness or the medication. /.../

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